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Umbhali: Smartweigh–Multihead Weighter
Iinketho ezine zokupakishwa kwe-aseptic ekufuneka ziqwalaselwe. Namhlanje, iitekhnoloji ezahlukeneyo ezijolise kubenzi bamayeza kunye ne-biopharmaceutical zezi: (1) iiklasi ezipheleleyo ze-100 zamagumbi acocekileyo, (2) i-isolator, (3) izithintelo ezithintelweyo zokufikelela iinkqubo (RABS), (4) iinkqubo zokusetyenziswa okukodwa. Yeyiphi eyona ilungileyo kuwe? 1. Igumbi elicocekileyo le-100: Itekhnoloji yegumbi lokucoca yaphuhliswa ekuqaleni kwi-1960s ukuze isetyenziswe kwi-aerospace kunye namashishini ombane ukuphepha ukungcoliseka kwenxalenye encinci.
Iintsholongwane ngamasuntswana, yaye ishishini loxubo-mayeza lakhawuleza laqonda ukuba obu buchule bunokuqinisekisa umoya ongenazintsholongwane. aleksandarlittlewolf - www.freepik.comPharma-gowning-young-technologist-putting-protective-rubber-gloves-production-factory-freepik-web.jpg Amagumbi acocekileyo oMdiba we-100 ngawona axhaphakileyo kwimveliso ye-aseptic (ISO 5 kunye ne-A/B yokusebenza kweKlasi ilingana), usebenzisa i-high-efficiency particulate air (HEPA) filter ukususa onke amasuntswana kunye neebhaktheriya. Umthamo omkhulu we-laminar okanye ukuhamba komoya unidirectional kunciphisa ukuhanjiswa kwamaqhekeza ukusuka kwenye indawo ukuya kwenye.
Ngeminyaka yee-1970, ukuzaliswa kwe-aseptic kwenziwa koomatshini abakhethekileyo phantsi kweephaneli zokucoca i-HEPA. Amalungu omatshini angentla kwesikhongozeli anokuba ngumthombo wongcoliseko, kwaye ekuhambeni kwexesha ashukunyiswa kangangoko kunokwenzeka ngaphantsi kwenqanaba lokusebenza. Ukugxininisa ngcono umoya ocociweyo kumatshini, iifestile zeplastiki ezifakwe kwiifestile nazo zongezwa.
Ilaphu lefestile liphinda likhumbuze umqhubi ukuba aphephe ukubamba umatshini okanye imveliso. Abavelisi baphendukela kwi-100% yeesilingi ze-HEPA ukulawula amagumbi onke ukuya kwiklasi ye-100. Oku kuphucula ulawulo, kodwa kwandisa iindleko kunye neendleko zokusebenza, ngakumbi inkqubo yokuphatha umoya.
2. I-Opto-Isolators: Kwi-80 kunye ne-90s, i-isolator yaphuhliswa ukuphucula umqobo phakathi kwabantu kunye neemveliso ngelixa kunciphisa iindleko. I-isolator ichazwa njengegumbi elicocekileyo kwibhokisi. Yonke inkqubo ivaliwe kwikhabhinethi etywiniweyo, ixinzelelwe ngomoya ohluzwe yi-HEPA filters.
Ngexesha lokusebenza, akukho mqhubi uvunyelwe ukuba angene ngaphandle kwe-interface yeglavu. Umfanekiso ngoncedo lwe-chase-logeman anchaselogeman-isolator-web.jpg yenkqubo yokwahlula (iyunithi ephezulu yokucoca i-HEPA ayiboniswanga). Umfanekiso ngoncedo lwe-chase-logeman anchase-logman-isolator-inside-web.jpg ityisa indawo engaphakathi eyedwa ebonisa izibuko leglavu.
Emva kokuqhutywa kwemveliso, i-isolator iya kuvulwa, icocwe, kwaye ilungele ukubaleka okulandelayo. Nje ukuba iphinde yatywinwa, i-isolator izaliswe yintsholongwane, edla ngokuba ngumphunga we-hydrogen peroxide (VHP), ukuvala inzala yonke into engaphakathi. Ngokungafaniyo nesitshizi sesintu okanye isibulali-ntsholongwane, i-VHP ingena kweyona mingxuma incinci.
Nje ukuba kwenziwe inzala, naluphi na ulungiselelo lokugqibela lwenziwa ngezibuko leglavu. Kwithiyori, kufuneka kube nokwenzeka ukuba kusebenze i-isolator kwindawo engalawulwayo, njengendawo yokugcina impahla, ngumqhubi onxibe idyasi yelebhu. Ngokwethiyori kunjalo.
Ngapha koko, iinkampani ezininzi ziye zafaka i-isolator kumagumbi acocekileyo eklasi ye-100. Oku kunika umaleko owongezelelweyo wokucoca, kodwa ixabiso kukuphuhlisa i-isolator ukuphepha. 3. Inkqubo yoMthintelo woFikelelo oluMiselweyo (i-RABS): I-RABS i-compromise phakathi kwenkqubo evulekileyo kunye nenkqubo eyedwa, i-RABS iqulethe inkqubo ngaphakathi kwendawo evaliweyo eqinile.
Ungenelelo olusebenzayo lungena ngezibuko leglavu. Syntegon Pharma technologies Syntegon-Pharma- products_filling and Closing_FXS_3100-web.jpg I-RABS evulekileyo inabela kwisilingi, ixhomekeke kulawulo lomoya lwegumbi kunye nenkqubo yokucoca. I-RABS evaliweyo iqulethe i-air hand handling and filtration system yayo.
I-RABS ineenzuzo ezibalulekileyo zeendleko ngaphezu kwezahlukanisi ngenxa yokulula kwayo. Oku kuyinyani ngakumbi ukuba zinokubekwa kumagumbi acocekileyo asele zikhona kwaye ke kuncitshiswe iindleko zokwakha. Isidingo sokwakha igumbi elicocekileyo linciphisa ezinye iindleko zokonga xa kuthelekiswa nezahlukanisi.
4. Iinkqubo ezilahlayo: Iinkqubo zokuphatha imveliso ezilahlayo ziya zithandwa ngakumbi kwizicelo ze-aseptic. Ezi nkqubo ziqulathe ingxowa yeplastiki endaweni yetoti yentsimbi yesintu. Ibhegi iza ipakishwe kwangaphambili nazo zonke izihluzi, iityhubhu, amazibuko, imilomo yokuzalisa, kunye nezinye izixhobo ezifunekayo.
Ivalwe kwingxowa yokukhusela kwaye ifakwe inzalo. Isixhobo somenzi sigqibezela inkqubo enyumba kwaye ilungele ukusebenza. Umfanekiso ngoncedo lwe-sartorioussaritus Img_OctoPlus-_4154-web.jpg Abanye abavelisi babonelela ngeenkqubo zesiko ezisetyenziswa kanye, kubandakanywa iSartorius (i-PreVAS yayo - iqinisekisiwe kwangaphambili, idityaniswe kwangaphambili, i-Syntegon yeProjekthi), iPall Corporation (iBiotech yayo kanye ukuSetyenziswa ngokweSondo Inkqubo) njl.
NgokukaMarion Monstier, uManejala weeMveliso zeSartorius Freeze-Thaw, iingenelo zenkqubo enye yokusetyenziswa ziquka: • Iinkqubo ezivaliweyo zinciphisa ugqithiso lwemveliso kunye nokuphathwa, ukunciphisa umngcipheko wongcoliseko. • Ukutshintsha iinkqubo zokusetyenziswa okukodwa phakathi kokuqhutywa kwemveliso kuphelisa ukungcoliseka okunokwenzeka ngenxa yokungaphelelanga okanye ukucoca okungafanelekanga. • Xa kuthelekiswa neenkqubo ezinokusetyenziswa kwakhona, ezi nkqubo zingezinye zinciphisa utshintsho kunye nexesha lokuseta.
• Baphelisa iimfuno zokuqinisekisa ukucoca. • Zikhupha amanzi ngcono, ngaloo ndlela zinyusa ukufunyanwa kwemveliso.
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